Multitube esophageal brachytherapy catheter

ABSTRACT

A system for delivery of radiation to a target portion of a native tissue is provided. The system includes a catheter having a catheter body with a proximal portion, a distal portion, and a longitudinally oriented lumen therebetween. The system further includes an expansion device disposed about at least a portion of the catheter body and having an expanded configuration and a non-expanded configuration. The system also includes a plurality of tubes disposed about at least a portion of the expansion device. Each of the plurality of tubes is configured to selectively guide exposure of a radiation source to the target portion of the native tissue.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/198,793 filed on 6 Mar. 2014, which claims priority to U.S.Provisional Application No. 61/777,671, filed 12 Mar. 2013. The subjectmatter of all applications is incorporated herein by reference in theirentirety.

TECHNICAL FIELD

The present invention relates to an apparatus that includes a deliverysystem for radiation treatments and, more particularly, to a radiationdelivery system for use with brachytherapy.

BACKGROUND OF THE INVENTION

During a radiation treatment session, it may be helpful for a medicalprofessional to fine-tune the exposure of a tumor to supplied radiation.An example of such a radiation treatment session may be a brachytherapyradiation treatment session, whereby a catheter is inserted into apatient's esophagus so that radiation may be supplied to a tumor via anexit port of the catheter.

However, such known brachytherapy catheters may have disadvantages. Forexample, the catheter may be configured to deliver only a small amountof radiation to the tumor. Thus, it may be desirable, in certain useenvironments, to deliver an increased quantity of radiation to thetumor. In another example, the catheter may be difficult to pass throughthe esophagus to the tumor, or the catheter may be difficult to positionas desired adjacent the tumor. Thus, a catheter that may be extendedthrough an esophagus and positioned adjacent to a tumor may bedesirable.

SUMMARY OF THE INVENTION

In an embodiment of the present invention, a system for delivery ofradiation to a target portion of a native tissue is provided during abrachytherapy treatment session. The brachytherapy system includes acatheter that has a main catheter body. The main catheter body includesan outer catheter surface and an inner catheter surface that defines alongitudinally oriented lumen. The lumen extends between longitudinallyspaced proximal and distal catheter face surfaces that extend laterallybetween the inner and outer catheter surfaces. A sheath covers at leasta portion of the outer catheter surface. The sheath includes a taperedportion that protrudes substantially longitudinally distally from aportion of the distal catheter face surface. A plurality of tubesextends through the lumen towards the distal catheter face surface. Eachtube of the plurality of tubes is configured to selectively guideexposure of a radiation source to the target portion of the nativetissue.

In an embodiment of the present invention, a system for selectivedelivery of radiation to a target portion of a native tissue during abrachytherapy treatment session is provided. The system includes aplurality of tubes connected together in a tube configuration at leastpartially responsive to a configuration of the target portion of thenative tissue. Each tube of the plurality of tubes terminates at a firstside of a terminal plane located at a distal end of the plurality oftubes. Each tube of the plurality of tubes is configured to guideexposure of a radiation source to the target portion of the nativetissue. At least one plug is configured to fit within at least one tubeof the plurality of tubes. The at least one plug is configured toselectively prevent exposure of the radiation source from at least onetube of the plurality of tubes to the target portion of the nativetissue.

In an embodiment of the present invention, a method of selectivelydelivering radiation to a target portion of a native tissue is provided.A delivery system is provided. The delivery system includes a catheterthat has a main catheter body. The main catheter body includes an outercatheter surface and an inner catheter surface that defines alongitudinally oriented lumen. The lumen extends between longitudinallyspaced proximal and distal catheter face surfaces that extend laterallybetween the inner and outer catheter surfaces. A sheath covers at leasta portion of the outer catheter surface. The sheath includes a taperedportion that protrudes substantially longitudinally distally from thedistal catheter face surface. A plurality of tubes extends through thelumen towards the distal catheter face surface. Each tube of theplurality of tubes is configured to selectively guide exposure of aradiation source to the target portion of the native tissue. Thedelivery system is positioned in a desired position relative to thetarget portion of the native tissue. A radiation-absorbing plug isinserted into a first chosen amount of tubes of the plurality of tubesto selectively prevent passage of a corresponding radiation sourcetherethrough. A radiation source is inserted into a second chosen amountof tubes of the plurality of tubes. The at least one radiation source isapplied to the target portion of the native tissue through the secondchosen amount of tubes of the plurality of tubes.

In another embodiment, a system for delivery of radiation to a targetportion of a native tissue is provided. The system includes a cathetercomprising a catheter body having a proximal portion, a distal portion,and a longitudinally oriented lumen extending between the proximal anddistal portions. The system further includes an expansion devicedisposed about at least a portion of the catheter body and having anexpanded configuration and a non-expanded configuration. The system alsoincludes a plurality of tubes disposed about at least a portion of theexpansion device, each of the plurality of tubes being configured toselectively guide exposure of a radiation source to the target portionof the native tissue.

In another embodiment, a method of selectively delivering radiation to atarget portion of a native tissue is provided. The method comprisesinserting a radiation delivery system into a patient's native tissue.The radiation delivery system comprises a catheter comprising a catheterbody having a proximal portion, a distal portion comprising a taperedtip with a closed distal end, and a longitudinally oriented lumenextending between the proximal and distal portions. The delivery systemfurther includes an expansion device disposed about at least a portionof the catheter body and having an expanded configuration and anon-expanded configuration. The system also includes a plurality oftubes disposed about at least a portion of the expansion device, each ofthe plurality of tubes being configured to selectively guide exposure ofa radiation source to the target portion of the native tissue. Themethod further includes inflating an anchor balloon at the native tissueor the target portion of the native tissue. The method also includesadjusting the radial position of the plurality of tubes by expanding theexpansion device to radially move the plurality of tubes in closerproximity to the native tissue or the target portion of the nativetissue. The method also includes applying radiation to the targetportion of the native tissue.

In another embodiment, a method of selectively delivering radiation to atarget portion of a native tissue is provided. The method comprisesinserting a radiation delivery system into a patient's native tissue.The radiation delivery system includes a catheter comprising a catheterbody having a proximal portion, a distal portion, and a longitudinallyoriented lumen extending therebetween, the distal portion comprising atapered tip having a distal opening longitudinally aligned and in fluidcommunication with the longitudinally oriented lumen of the catheterbody. The delivery system further includes an expansion device disposedabout at least a portion of the catheter body and having an expandedconfiguration and a non-expanded configuration. The delivery systemfurther includes a plurality of tubes disposed external to the expansiondevice, each of the plurality of tubes being configured to selectivelyguide exposure of a radiation source to the target portion of the nativetissue. The method also includes inserting an anchor balloon through thelongitudinally oriented lumen and distal opening of the tapered tip. Themethod further includes adjusting the radial position of the pluralityof tubes by expanding the expansion device to radially move theplurality of tubes in closer proximity to the native tissue or thetarget portion of the native tissue. The method also includes applyingradiation to the target portion of the native tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, reference may be made tothe accompanying drawings, in which:

FIG. 1 is a first side perspective view of an embodiment of the presentinvention;

FIG. 2 is a schematic side view of the embodiment of FIG. 1;

FIG. 3 is a front view of the embodiment of FIG. 1;

FIG. 4 is a second side perspective view of a portion of the embodimentof FIG. 1;

FIG. 5 is a front view of the embodiment of FIG. 1;

FIG. 6 is a third side perspective view of the embodiment of FIG. 1;

FIG. 7 is a front view of the embodiment of FIG. 1;

FIGS. 8 and 9 are side perspective views of the embodiment of FIG. 1having various configurations;

FIG. 10 is a side perspective view of an embodiment of the presentinvention;

FIG. 11 is a front view of the embodiment of FIG. 10;

FIG. 12 is a side view of the embodiment of FIG. 10;

FIG. 13 is a flow chart illustrating an example process for using anembodiment of the present invention;

FIGS. 14-17 are perspective views depicting a sequence of operation ofthe present invention;

FIG. 18 is a side view of an embodiment of the present invention;

FIG. 19 is a side view of an embodiment of the present invention;

FIG. 20 is a flow chart illustrating an example process for using anembodiment of the present invention; and

FIG. 21 is a flow chart illustrating an example process for using anembodiment of the present invention.

DESCRIPTION OF EMBODIMENTS

The following description presumes that the systems and methodsdescribed are being used in conjunction with brachytherapy, but thesystems and methods described may be used similarly in any desiredmanner and for desired purpose without harm to the present invention.

In accordance with an embodiment of the present invention, FIGS. 1-9depict a delivery system 10. The delivery system 10 may be used for thedelivery of at least one radiation source to a target portion of anative tissue. As used herein, the term “native tissue” (and variantsthereof) refers to a portion of the patient's body that is of interest,in its condition (congenital or acquired) at the time of surgicalpreparation. As used herein, the term “target portion” of a nativetissue (and variants thereof) refers to a portion of the native tissue(e.g., a tumor, a lesion, etc.) that may be treated using the deliverysystem 10. However, it will be appreciated that the delivery system 10may be used with any desired portion of any native tissue of the patient(e.g., esophagus, trachea, stomach, small intestine, large intestine,etc.) for any desired reason or purpose.

As shown in FIG. 1, the delivery system 10 includes a catheter 12 with amain catheter body 14. The main catheter body 14 may be generallycircular (or have any other desired cross-sectional shape), and mayextend concentrically about a longitudinal axis A. The main catheterbody 14 has a length which may be, for example, up to, and including,approximately 1.5 m, and a cross-sectional area which may be, forexample, up to, and including, approximately 13 mm for certain uses ofthe present invention. The main catheter body 14 may be made of a hardplastic (e.g., polyurethane, etc.), a soft plastic (e.g., polyethylene,polypropylene, polyvinyl chloride, etc.), a radioactive material (e.g.,technetium-99m, iodine, etc.), or any other suitable material or acombination of materials. The main catheter body 14 shown in FIG. 1 hasa semi-rigid configuration or a flexible configuration to assist withnavigational efficiency of the delivery system 10 through the patient'sbody.

The main catheter body 14 includes an outer catheter surface 16 and aninner catheter surface 18. The main catheter body 14 also includes aproximal catheter face surface 20 longitudinally spaced from a distalcatheter face surface 22 along the longitudinal axis A. The proximal anddistal catheter face surfaces 20 and 22 extend laterally between theouter and inner catheter surfaces 16 and 18. As used herein, the term“laterally” (and variants thereof) refers to a direction substantiallylocated within or along a lateral plane which is substantiallycross-sectionally perpendicular to the longitudinal axis A. The innercatheter surface 18 defines a longitudinally oriented lumen 24. Thelumen 24 extends between the proximal and distal catheter face surfaces20 and 22. A guidewire (not shown) may be inserted through the lumen 24to help guide the delivery system 10 during navigation through thepatient's body.

A sheath 26 may be attached to at least a portion of the main catheterbody 14. For example, the sheath may be affixed to the main catheterbody 14. However, it will be appreciated that the sheath 26 may also orinstead be detachable from the main catheter body 14. The sheath 26covers at least a portion of the distal catheter face surface 22. Forexample, the sheath 26 may be installed onto the main catheter body 14so that a portion of the sheath extends distally from the distalcatheter face surface 22. It will be appreciated that the sheath 26 maybe attached, permanently or temporarily, to any suitable portion of themain catheter body 14 (e.g., the entire outer catheter surface 16, aregion of the main catheter body near the distal catheter face surface22, etc.). The sheath 26 may be made of a soft plastic (e.g.,polyethylene, polypropylene, polyvinyl chloride, etc.), or any othersuitable material or a combination of materials.

The sheath 26 includes a tapered portion 28 that protrudes substantiallylongitudinally distally from a portion of the distal catheter facesurface 22. It will be appreciated that the tapered portion 28 may haveany suitable configuration (e.g., a substantially flat configuration).In one example, the tapered portion 28 may be integrally formed with thesheath 26. In another example, the tapered portion 28 may be attached tothe sheath 26 by any suitable method (e.g., welding, adhesives,encircling band, etc.). As shown in FIG. 2, the tapered portion 28 maybe configured as a flap-like portion. However, it will be appreciatedthat the tapered portion 28 may have any suitable configuration (e.g., aspike, a ramp, etc.). The tapered portion 28 may have a semi-rigidconfiguration or a flexible configuration, as desired, to help guide thedelivery system 10 through the native tissue. For example, as shown inFIG. 1, the tapered portion 28 is generally coaxial with thelongitudinal axis A. However, as shown in FIG. 2, the tapered portion 28may be temporarily or permanently deflected upwards or downwardsrelative to the longitudinal axis A, as described in more detail below.

The tapered portion 28 may be generally made of the same material as thesheath 26. However, it will be appreciated that the tapered portion 28may be made of any other suitable material or a combination of materialsto allow the tapered portion to be deflected in a direction upwards ordownwards relative to the longitudinal axis A. Regardless of thematerial comprising the tapered portion 28, the tapered portion isconfigured to temporarily or permanently maintain a deflected positionrelative to the longitudinal axis A to allow the delivery system 10 tonavigate through the patient's body, such deflection being facilitatedby the tapered portion being at least partially pliable based on thematerial comprising the tapered portion. In one example, a user maydeflect the tapered portion 28 into a desired position, which ismaintained relative to the longitudinal axis A, before the deliverysystem 10 is inserted into the patient's body. In another example, thetapered portion 28 may be deflected relative to the longitudinal axis Aupon contact with a portion of the patient's body (e.g., a particularlybulky portion of the native tissue). It will be appreciated that thetapered portion 28 may maintain its deflected position until an appliedforce (e.g., by the user or a portion of the patient's body) acts uponthe tapered portion to adjust the tapered portion into another deflectedposition. For example, the tapered portion 28 may be further deflectedrelative to the longitudinal axis A, or the tapered portion may bemanipulated back into its original, substantially parallel relationshipwith the longitudinal axis.

The delivery system 10 is configured to deliver a desired quantity ofradiation, described herein as being provided in discrete radiationsources, to the target portion of the native tissue. The delivery system10 may include a plurality of tubes 30 that includes multiple individualtubes 32. Each tube 32 may be configured to provide a radiation sourcefor delivery to the target portion of the native tissue, as described inmore detail below. The tubes 32 are positioned relative to each other ina tube configuration at least partially responsive to a configuration ofthe target portion of the native tissue. In some use environments, thenumber of tubes 32 in the plurality of tubes 30 ranges from seven tubesto eleven tubes. In other use environments, the plurality of tubes 30includes nine tubes 32.

For use as described herein, each tube 32 may have a generally circularcross-sectional shape, and may be made of a hard plastic (e.g.,polyurethane, etc.), a soft plastic (e.g., polyethylene, polypropylene,polyvinyl chloride, etc.), or any other suitable material or acombination of materials. Each tube 32 may have a length which can be,for example, up to, and including, approximately 1.5 m, and across-sectional area which can be, for example, up to, and including,approximately 3 mm for certain uses of the present invention. The tubes32 have a semi-rigid configuration or a flexible configuration, asdesired, to deliver radiation to the target portion. Some or all of thetubes 32 may be attached to one another in a known manner (e.g.,welding, adhesives, encircling band, etc.) sufficient to maintain therelative positions of the tubes to one another during use.

The plurality of tubes 30 extend through the lumen 24 from the proximalcatheter face surface 20 to the distal catheter face surface 22. In oneexample, the plurality of tubes 30 is arranged about a circumference ofthe inner catheter surface 18. The plurality of tubes 30 may be urgedagainst the inner catheter surface 18, as shown in FIG. 1, in afriction-fit configuration. In another example, the plurality of tubes30 may be spaced from the inner catheter surface 18, and may be attachedto the inner catheter surface by any suitable mechanism (not shown)(e.g., cables, rods, etc.). The plurality of tubes 30 may have asubstantially circular arrangement about the longitudinal axis A whenviewed from the distal catheter face surface 22. In one example, theplurality of tubes 30 may abut the distal catheter face surface 22. Inanother example, the plurality of tubes may be spaced from the distalcatheter face surface 22. As shown in FIG. 3, each tube 32 of theplurality of tubes 30 longitudinally terminates at the distal catheterface surface 22 such that none of the tubes extend distally from thedistal catheter face surface. Each tube 32 of the plurality of tubes 30is configured to selectively guide exposure of a radiation source to thetarget portion of the native tissue as desired, as described in moredetail below.

As shown in FIGS. 4 and 5, the delivery system 10 may include at leastone plug 34 that is sized and dimensioned to fit tightly within one ormore chosen tubes 32 of the plurality of tubes 30. The plugs 34 may havea length which can be, for example, up to, and including, approximately1.5 m, and a cross-sectional area which can be, for example, up to, andincluding, approximately 2.5 mm. It will be appreciated that the plugs34 may have sizes and dimensions slightly less than the sizes anddimensions of the corresponding tubes 32 to allow the plugs to snuglyfit within the tubes and prevent the plugs from unwanted movement withinthe tubes. The plugs 34 may have a friction-fit with the tubes 32, theplugs may be installed within the tubes with an adhesive (e.g., glue,putty, etc.), or any other suitable means may be provided to retain theplugs within the tubes (e.g., a seal or gate over the tube openings).The plugs 34 may have a completely rigid configuration, a semi-rigidconfiguration, or a flexible configuration to allow the plugs to beinserted easily into the tubes 32. The plugs 34 may have a generallycircular cross-sectional shape, as shown; however, it will beappreciated that the plugs may have any shape that may be selected, forexample, responsive to the internal configuration of the tubes 32. Theplugs 34 may be at least partially made of a radiation-absorbingmaterial (e.g., lead, barium sulfate, etc.). The plugs 34 mayselectively prevent passage of radiation from the corresponding one ormore chosen tubes 32 to the target portion of the native tissue.

As depicted in FIGS. 6-9, the delivery system 10 may further include atleast one arrangement mechanism 36 affixed to a portion of the maincatheter body 14. FIGS. 6 and 7 show that the arrangement mechanisms 36may be disposed about at least a portion of the outer catheter surface16. As depicted in FIGS. 6 and 7, the arrangement mechanisms 36 may beaffixed to a portion of the sheath 26 that overlies the outer cathetersurface 16. It will be appreciated that the arrangement mechanisms 36may be located on any other suitable portion of the main catheter body14 (e.g., the inner catheter surface 18). The arrangement mechanisms 36,when present, may help position and anchor the delivery system 10 bybracing against a portion of the native tissue.

FIGS. 8 and 9 depict the arrangement mechanisms 36 configured as one ormore selectively inflatable balloons. It will be appreciated that thearrangement mechanisms 36 may be configured as any suitable mechanism(e.g., rods, plates, etc.) to position the delivery system 10 relativeto the native tissue, and/or anchor the delivery system against aportion of the native tissue, as desired. In one example, shown in FIG.8, the delivery system 10 includes a single arrangement mechanism 36that anchors and/or positions the delivery system relative to the nativetissue. In this instance, the single arrangement mechanism 36 iscircumferential about the outer catheter surface 16, similar to acatheter balloon. In another example, shown in FIG. 9, the deliverysystem 10 includes multiple arrangement mechanisms 36 that anchor and/orposition the delivery system relative to the native tissue. In thisinstance, the multiple arrangement mechanisms 36 are arranged in aspaced-apart relation to one another on a portion of the outer cathetersurface 16. The multiple arrangement mechanisms 36 may be arranged inany longitudinal or lateral configuration (e.g., offset, spaced fromeach other, adjacent, etc.) with respect to the main catheter body 14 toposition the delivery system 10 as desired relative to the nativetissue. The arrangement mechanisms 36 may be selectively inflated tocontact the native tissue for anchoring and/or positioning the deliverysystem 10 relative to the native tissue, as discussed in more detailbelow.

FIGS. 10-12 illustrate another embodiment of the delivery system 10. Thedelivery system 10′ of FIGS. 10-12 is similar to the delivery system ofFIGS. 1-9 and, therefore, structures of FIGS. 10-12 that are the sameas, or similar to, those described with reference to FIGS. 1-9 have thesame reference numbers with the addition of a “prime” mark. Descriptionof common elements and operation similar to those in the previouslydescribed embodiment will not be repeated with respect to the currentlydescribed embodiment.

The delivery system 10′ includes a plurality of tubes 30′ with multipleindividual tubes 32′, but without the catheter 12 of the delivery system10. In one example, the number of tubes 32′ in the plurality of tubes30′ may range from seven tubes to eleven tubes. In another example, thedelivery system 10′ includes nine tubes 32′. Each tube 32′ of theplurality of tubes 30′ is disposed at a terminal plane 38 that defines aproximal plane side 40 and a distal plane side 42. Each tube 32′ of theplurality of tubes 30′ longitudinally terminates at the proximal planeside 40 such that each tube 32′ does not substantially extend into thedistal plane side 42, as shown in FIGS. 11 and 12.

As shown in FIG. 10, the delivery system 10′ includes a portion of thesheath 26′.

The sheath 26′ is affixed to a collective distal end 44 of each tube 32′of the plurality of tubes 30′ substantially disposed on the proximalplane side 40 of the terminal plane 38. It will be appreciated that thecollective distal end 44 of the tubes 32′ may generally correspond tothe proximal plane side 40. In this use environment, the tapered portion28′ of the sheath 26′ extends from the collective distal end 44 of theplurality of tubes 30′, through the terminal plane 38, and into thedistal plane side 42.

FIG. 13 shows a flow chart 200 representing a sequence of use of thedelivery systems 10 and 10′ during a brachytherapy treatment session. Ina first action block 202 of the flow chart 200, the delivery system 10,as described above, is provided.

In a second action block 204 of the flow chart 200, the delivery system10 is positioned relative to a native tissue 46. As shown in FIG. 14,the delivery system 10 is inserted into a portion of the native tissue46 near a target portion 48 thereof. In one example, the delivery system10 is positioned such that the plurality of tubes 30 is approximatelyadjacent to at least an outer contour of the target portion 48. Inanother example, the delivery system 10 is positioned such that theplurality of tubes 30 contacts at least the outer contour of the targetportion 48.

The tapered portion 28 of the sheath 26 may include a semi-rigidconfiguration or a flexible configuration to act as a guide for helpingnavigation of the delivery system 10 through the native tissue 46. Thetapered portion 28 may be made of a suitably pliable material to allowthe tapered portion to be deflected upwards or downwards relative to thelongitudinal axis A. In one example, a user may deflect the taperedportion upwards or downwards relative to the longitudinal axis A into adesired position relative to the longitudinal axis before the deliverysystem 10 is inserted into the patient's body. The deflected position ofthe tapered portion 28 may assist in navigation of the delivery system10 through the native tissue 46. Additionally, the deflected position ofthe tapered portion 28 may also assist with placement of the pluralityof tubes 30 in a desired position relative to the target portion 48(e.g., adjacent to the target portion, contacting the target portion,etc.). In another example, the tapered portion 28 may be sized anddimensioned to provide leverage to create clearance for the deliverysystem 10 to extend past, e.g., a particularly bulky portion of thenative tissue 46. In a further example, the tapered portion 28 may bedeflected relative to the longitudinal axis A upon contact with aportion of the patient's body (e.g., a particularly bulky portion of thenative tissue). Regardless of the manner in which the tapered portion isdeflected, the now-deflected tapered portion 28 may allow the deliverysystem 10 to “cup” the target portion 48, as shown in FIG. 15, therebyincreasing the surface area of the target portion that is contacted bythe plurality of tubes 30.

Once the tapered portion 28 has been deflected, it will be appreciatedthat the tapered portion may maintain its deflected position untilanother force (e.g., the user or a portion of the patient's body) actsupon the tapered portion to deflect the tapered portion into anotherdeflected position. For example, the tapered portion 28 may be furtherdeflected relative to the longitudinal axis A, or the tapered portioncan be manipulated back into a non-deflected, coaxial relationship withthe longitudinal axis. In another example, the tapered portion 28 may beat least partially comprised of a shape memory material (e.g., nitinol,etc.) to allow the tapered portion to return to the non-deflectedoriginal position. In a further example, the tapered portion can includea spring-biased or other movement mechanism (not shown) to deflect thetapered position into the non-deflected position or another deflectedposition.

The delivery system 10 may be anchored, at any desired time in the useprocess, to the native tissue 46 relative to the target portion 48. Thearrangement mechanisms 36 may be selectively inflated to anchor andposition the delivery system 10 relative to the target portion 48. Asshown in FIG. 16, the arrangement mechanisms 36 may be inflated tocontact portions (e.g., tangential surfaces) of the surrounding nativetissue 46. The arrangement mechanisms 36 may be inflated to a desiredamount until the delivery system 10 is urged against the native tissue46, thereby anchoring and positioning the delivery system relative tothe target portion 48. For example, multiple arrangement mechanisms 36can be inflated to different degrees relative to each other to allow foran off-center, or any other desired, placement of the delivery system 10against the native tissue 46.

Once the delivery system 10 is positioned and anchored in a desiredposition relative to the target portion 48, at least one radiationsource may be exposed to the target portion. In a third action block 206of the flow chart 200, a radiation source may be individually insertedinto a chosen amount of tubes 32. The radiation source may be anysuitable form of radiation-providing material (e.g., a solid rod, aseed-like structure containing a radioactive material, a fluid, etc.).In one example, a radiation source may be inserted into each tube 32. Inanother example, a radiation source may be inserted into a first chosennumber (e.g., less than seven) of tubes 32.

In some use environments, it may be desirable to protect a “healthy”(e.g., non-target) portion of the native tissue 46 from exposure toradiation passing through the tubes 32 to the target portion. To preventsuch unwanted exposure, one or more plugs 34 may be inserted into asecond chosen number of tubes 32 (e.g., the remaining ones of theplurality of tubes 30 not included in the first chosen number of tubes).It will be appreciated that the plugs 34 may be inserted into the secondchosen number of tubes 32 before, during, or after the radiation sourcesare inserted into the first chosen number of tubes. Since the plugs 34are at least partially made of a radiation-absorbing material, the plugsmay help prevent unwanted radiation exposure to portions of the nativetissue 46 other than the target portion 48.

In a fourth action block 208 of the flow chart 200, the radiationsources are delivered to the target portion 48 of the native tissue 46,thereby exposing the target portion to the radiation. In one useenvironment, the radiation sources are positioned at the proximalcatheter face surface 20 to deliver radiation through the length of thechosen number of tubes 32 and out of the distal catheter face surface22. In this use environment, the radiation sources deliver radiationthrough the first chosen number of tubes 32, thereby exposing the targetportion 48 to the radiation. In another use environment, as shown inFIG. 17, the radiation sources extend through the length of the chosennumber of tubes 32 and are positioned at the distal catheter facesurface 22 to expose the target portion 48 to the radiation. In eitheruse environment, the radiation sources directly contact the targetportion 48, or are otherwise positioned adjacent the target portion,thereby exposing the target portion to the radiation. In any useenvironment, the plurality of tubes 30 facilitates exposure of thetarget portion 48 to a desired quantity of radiation. A deflectedposition of the tapered portion 28 may facilitate positioning of theplurality of tubes 30 in a desired relationship (e.g., relativelycloser) to the target portion 48, thereby increasing the exposure of thetarget portion to radiation.

In other aspects of the present invention, a system for delivery ofradiation to a target portion of a native tissue is provided thatincludes an expansion device. Such an expansion device allows a user toadjust the radial position of the plurality of tubes. For example, suchan expansion device allows a user to radially move the plurality oftubes in closer proximity the native tissue or the target portion of thenative tissue.

For example, referring to FIG. 18, in certain embodiments, a system 61includes a catheter 60 comprising a catheter body 65 having a proximalportion (not shown), a distal portion 62, and a longitudinally orientedlumen extending therebetween. Referring to FIG. 19, system 61 canfurther include an expansion device 82 disposed about at least a portionof catheter body 65. Expansion device 82 can assume an expandedconfiguration and a non-expanded configuration. As such, expansiondevice can be fabricated of any suitable material that allows the deviceto assume such configurations. For example, expansion device can have anouter layer fabricated from silicone rubber and an inner layerfabricated from a nylon elastomer. System 61 can further include aplurality of tubes 78 disposed about at least a portion of expansiondevice 82. As described above, each of the plurality of tubes 78 areconfigured to selectively guide exposure of a radiation source to thetarget portion of the native tissue.

Distal portion 62 of catheter body 65 can have a tapered tip 66 asillustrated in FIGS. 18 and 19. In certain embodiments, the tapered tiphas a closed distal end and in other embodiments, the tapered tip has adistal opening longitudinally aligned and in fluid communication withthe longitudinally oriented lumen of catheter body 65. The tapered tipcan be fabricated from an elastomeric material. Referring to FIG. 19, incertain embodiments, the longitudinally oriented lumen of catheter body65 has a longitudinal axis and distal portion 62 of catheter body 65defines a lateral port 64 that is non-concentric with the longitudinalaxis. A guidewire can be urged through lateral port 64 and thereforefacilitate guidewire navigation. Preferably, lateral port 64 is includedin embodiments where the tapered tip of the catheter body has a closeddistal end.

Referring to FIG. 18, in certain embodiments, a sheath 68 having adistal portion 70 and a proximal portion 72 is disposed about at least aportion of catheter 60 proximal to distal tip 66. At least portions ofsheath 68 may be fabricated from an elastomeric material, which allowsit to be introduced and/or retracted in a small diameter state, yetaccommodate expandable device 82 and anchor balloon 76 (describedbelow). For example, distal portion 70 of sheath 68 can house expandabledevice 82 and anchor balloon 76 and therefore be fabricated from anexpandable material whereas proximal portion 72 can be fabricated from anon-expandable material. Portions 70 and 72 may be sealed at a seam 74or otherwise connected and in fluid communication with one another.

Referring to FIGS. 18 and 19, in certain embodiments, an anchor balloon76 can be disposed about distal portion 62 of catheter body 65 (proximalto distal tip 66 and distal to expandable device 82) and can assume aninflated and deflated configuration. Anchor balloon 76 can be disposedinside of sheath 68 in a deflated configuration and extend outside ofsheath 68 in an inflated configuration as shown in FIG. 18. Anchorballoon 76 may be used for several purposes. For example, the anchorballoon can be used to dilate the native tissue, such as the esophagus,for example, when introducing system 61 into a stricture; secure theposition of system 61 within the native tissue, such as the esophagus orstomach, for example, at the gastroesophageal junction (GEJ); and/orreposition the plurality of plurality of tubes 78 in closer proximity toa target portion of native tissue, such as a tumor involving the GEJ andproximal gastric cardia.

Referring to FIG. 18, at least a portion of plurality of tubes 78 isdisposed inside of sheath 68. The plurality of tubes can be disposedsubstantially parallel to each other. As shown in FIG. 18, a distalsection 80 of the plurality of tubes 78 can be disposed on anchorballoon 76 so that when anchor balloon 76 is inflated, distal section 80of the plurality of tubes 76 is deflected radially. Such a configurationmay be useful when treating the GEJ and proximal gastric cardia. Theplurality of tubes 78 can incorporate fiducial markers visible undervarious types of imaging.

In certain embodiments, a delivery system further includes a mouth guarddisposed at the proximal portion of the catheter that can be placed inthe patient's mouth during treatment. Such a mouth guard can have acentral opening with a locking mechanism through which a medicalinstrument can be inserted. Such medical devices include, for example,any of the devices described herein including other transoral devicessuch as an esophagogastroduodenoscope with or without a guidewire. Sucha mouth guard can also serve as a bite block.

FIG. 20 shows a flow chart 300 representing a sequence of use of anembodiment of a delivery system 61 having a tapered closed distal tipduring a brachytherapy treatment session. In a first action block 302,system 61 can be inserted into a patient's native tissue. In a secondaction block 304, an anchor balloon 76 can be inflated at the nativetissue or the target portion of the native tissue. In a third actionblock 306, the radial position of the plurality of tubes 78 can beadjusted by expanding the expansion device 82 to radially move theplurality of tubes 78 in closer proximity to the native tissue or thetarget portion of the native tissue. In a fourth action block 308,radiation can be applied to the target portion of the native tissue.

Regarding a specific exemplary method, a mouth guard mounting unit canbe placed in the patient. An esophagogastroduodenoscopy with placementof a guide wire through an EGD scope into the stomach or esophagus canbe performed. The guide wire can be inserted through the lateral port ofthe catheter of system 61, as described above. System 61 can be insertedinto the patient's esophagus. Anchor balloon 76 can be inflated todilate the esophagus or the esophageal tumor, secure catheter 60, orreposition the plurality of tubes 78. If it is desired to treat the GEJor proximal gastric cardia, anchor balloon 76 can be inflated such thatthe plurality of tubes 78 is held in contact with the tissue of the GEJand proximal gastric cardia. The radial position of the plurality oftubes 78 can be adjusted by expanding expansion device 82 to radiallymove the plurality of tubes 78 in closer proximity to the esophagealwall and/or tumor. Plugs, as described above, can be placed in selectedtubes 78 to modulate the radiation dose and decrease the radiation doesto uninvolved, normal tissue. CT and/or MRI imaging can be completedwith system 61 in position for radiation treatment planning. Anoptimized radiation treatment plan using forward or inverse planning canbe used to deliver the radiation to the target portion of the nativetissue. After the treatment is completed, expansion device 82 can beretracted followed by deflation of anchor balloon 76. Delivery system 61can then be removed from the patient.

FIG. 21 shows a flow chart 400 representing a sequence of use of anembodiment of a delivery system 61 having an tapered open distal tipduring a brachytherapy treatment session. In a first action block 402,system 61 can be inserted into a patient's native tissue. In a secondaction block 404, an anchor balloon can be inserted through thelongitudinally oriented lumen of catheter 60 and through the distalopening of the tapered tip. In a third action block 406, the radialposition of the plurality of tubes 78 can be adjusted by expanding theexpansion device 82 to radially move the plurality of tubes 78 in closerproximity to the native tissue or the target portion of the nativetissue. In a fourth action block 408, radiation can be applied to thetarget portion of the native tissue.

Regarding a specific exemplary method, a mouth guard mounting unit canbe placed in the patient. An esophagogastroduodenoscopy with placementof a guide wire through an EGD scope into the stomach or esophagus canbe performed. A dilating balloon can be delivered through thelongitudinally oriented lumen of the catheter 60 of the delivery systemand through the distal opening of the tapered tip into the esophagusover a guidewire or together with a guidewire to dilate the esophagus orthe esophageal tumor. The dilating balloon can be removed after dilationwhile the guide wire remains in place in the longitudinally orientedlumen and open tapered tip. Delivery system 61 can be inserted into thepatient's esophagus over the guide wire. An anchor balloon can beinserted through the longitudinally oriented lumen of delivery system 61and through the distal opening of the tapered tip. The position ofcatheter 60 can be secured by inflating the anchor balloon and/orattaching catheter 60 to the mouth guard mounting unit. The anchorballoon can be inflated in the stomach or another location along theesophagus to secure delivery system 61. Alternatively, to avoidinterchanging a dilation balloon and an anchor balloon, the dilatingballoon can also serve as the anchor balloon. In other words, thedilating balloon can be inserted through the longitudinally orientedlumen of delivery system 61 and through the distal opening of thetapered tip and inserted together as a unit into the patient's esophagusalong the guidewire. To adjust the radial position of the plurality oftubes 76, the expansion device 82 can be expanded to radially move theplurality of tubes in closer proximity to the esophageal wall and/ortumor. Plugs, as described above, can be placed in selected tubes tomodulate the radiation dose and decrease the radiation does touninvolved, normal tissue. CT and/or MRI imaging can be completed withsystem 61 in position for radiation treatment planning. An optimizedradiation treatment plan using forward or inverse planning can be usedto deliver the radiation to the target portion of the native tissue.After the treatment is completed, expansion device 82 can be retractedfollowed by deflation of the anchor balloon. The anchor balloon can beremoved through the distal opening of the tapered tip and thelongitudinally oriented lumen of catheter 60. Delivery system 61 canthen be removed from the patient.

While aspects of the present invention have been particularly shown anddescribed with reference to the preferred embodiment above, it will beunderstood by those of ordinary skill in the art that various additionalembodiments may be contemplated without departing from the spirit andscope of the present invention. For example, the specific methodsdescribed above for using the delivery systems are merely illustrative;one of ordinary skill in the art could readily determine any number oftools, sequences of steps, or other means/options for placing theabove-described apparatus, or components thereof, into positionssubstantially similar to those shown and described herein. Any of thedescribed structures and components could be integrally formed as asingle unitary or monolithic piece or made up of separatesub-components, with either of these formations involving any suitablestock or bespoke components and/or any suitable material or combinationsof materials; however, the chosen material(s) should be biocompatiblefor many applications of the present invention. Though certaincomponents described herein are shown as having specific geometricshapes, all structures of the present invention may have any suitableshapes, sizes, configurations, relative relationships, cross-sectionalareas, or any other physical characteristics as desirable for aparticular application of the present invention. Unless otherwisespecifically stated, contact could be either direct or indirect. Anystructures or features described with reference to one embodiment orconfiguration of the present invention could be provided, singly or incombination with other structures or features, to any other embodimentor configuration, as it would be impractical to describe each of theembodiments and configurations discussed herein as having all of theoptions discussed with respect to all of the other embodiments andconfigurations. A device or method incorporating any of these featuresshould be understood to fall under the scope of the present invention asdetermined based upon the claims below and any equivalents thereof.

Other aspects, objects, and advantages of the present invention may beobtained from a study of the drawings, the disclosure, and the appendedclaims.

What is claimed is:
 1. A system for delivery of radiation to a targetportion of a native tissue, the system comprising: a catheter comprisinga catheter body having a proximal portion, a distal portion, and alongitudinally oriented lumen therebetween; an expansion device disposedabout at least a portion of the catheter body and having an expandedconfiguration and a non-expanded configuration; and a plurality of tubesdisposed about at least a portion of the expansion device, each of theplurality of tubes being configured to selectively guide exposure of aradiation source to the target portion of the native tissue.
 2. Thesystem of claim 1, wherein the distal portion of the catheter bodycomprises a tapered tip having a closed distal end.
 3. The system ofclaim 1, wherein the distal portion of the catheter body comprises atapered tip having a distal opening longitudinally aligned and in fluidcommunication with the longitudinally oriented lumen of the catheterbody.
 4. The system of claim 2, wherein the longitudinally orientedlumen has a longitudinal axis and the distal portion of the catheterbody defines a lateral port non-concentric with the longitudinal axis.5. The system of claim 2, further comprising an anchor balloon disposedabout the distal portion of the catheter body proximal to the taperedtip, the anchor balloon having an inflated configuration and a deflatedconfiguration.
 6. The system of claim 5, wherein the expansion device islocated proximal to the anchor balloon.
 7. The system of claim 5,wherein the plurality of tubes has a distal section disposed about atleast a portion of the anchor balloon.
 8. The system of claim 7, whereinthe distal section of the plurality of tubes is deflected radially whenthe anchor balloon assumes an inflated configuration.
 9. The system ofclaim 1, further comprising a sheath disposed at least partially aboutthe plurality of tubes.
 10. A method of selectively delivering radiationto a target portion of a native tissue, the method comprising: insertinga radiation delivery system into a patient's native tissue, theradiation delivery system comprising: a catheter comprising a catheterbody having a proximal portion, a distal portion comprising a taperedtip with a closed distal end, and a longitudinally oriented lumenextending between the proximal and distal portions; an expansion devicedisposed about at least a portion of the catheter body, the expansiondevice having an expanded configuration and a non-expandedconfiguration; and a plurality of tubes disposed about at least aportion of the expansion device, each of the plurality of tubes beingconfigured to selectively guide exposure of a radiation source to thetarget portion of the native tissue; inflating an anchor balloon at thenative tissue or the target portion of the native tissue; adjusting theradial position of the plurality of tubes by expanding the expansiondevice to radially move the plurality of tubes in closer proximity tothe native tissue or the target portion of the native tissue; andapplying radiation to the target portion of the native tissue.
 11. Themethod of claim 10, wherein the anchor balloon, in an inflatedconfiguration, dilates the native tissue.
 12. The method of claim 10,wherein the anchor balloon, in an inflated configuration secures theposition of the catheter within the native tissue.
 13. The method ofclaim 10, wherein the anchor balloon, in an inflated configuration,repositions the plurality of tubes in closer proximity to the targetportion of the native tissue.
 14. A method of selectively deliveringradiation to a target portion of a native tissue, the method comprising:inserting a radiation delivery system into a patient's native tissue,the radiation delivery system comprising: a catheter comprising acatheter body having a proximal portion, a distal portion, and alongitudinally oriented lumen extending therebetween, the distal portioncomprising a tapered tip having a distal opening longitudinally alignedand in fluid communication with the longitudinally oriented lumen of thecatheter body; an expansion device disposed about at least a portion ofthe catheter body, the expansion device having an expanded configurationand a non-expanded configuration; and a plurality of tubes disposedabout at least a portion of the expansion device, each of the pluralityof tubes being configured to selectively guide exposure of a radiationsource to the target portion of the native tissue; inserting an anchorballoon through the longitudinally oriented lumen and distal opening ofthe tapered tip; adjusting the radial position of the plurality of tubesby expanding the expansion device to radially move the plurality oftubes in closer proximity to the native tissue or the target portion ofthe native tissue; and applying radiation to the target portion of thenative tissue.
 15. The method of claim 14, wherein the anchor balloon,in an inflated configuration, dilates the native tissue.
 16. The methodof claim 14, wherein the anchor balloon, in an inflated configuration,secures the position of the catheter within the native tissue.
 17. Themethod of claim 14, wherein the anchor balloon, in an inflatedconfiguration, repositions the plurality of tubes in closer proximity tothe target portion of the native tissue.
 18. The method of claim 14,further comprising: delivering a dilating balloon into the esophagusprior to inserting the radiation delivery system; and inflating thedilating balloon to dilate the native tissue.
 19. The method of claim14, wherein the anchor balloon and the dilating balloon are the sameballoon.
 20. The method of claim 14, further comprising inserting amouth guard in the patient's mouth prior to inserting the radiationdelivery system.
 21. The method of claim 10, further comprisinginserting a mouth guard in the patient's mouth prior to inserting theradiation delivery system.